FDA 510(k)

Soteria E-View

K-Number: K242488 · 2025-01-06

Decision Date2025-01-06

Product CodeJAA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Soteria E-View is a medical device manufactured by Omega Medical Imaging, LLC. It received FDA 510(k) clearance on 2025-01-06 under approval number K242488. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Soteria E-View?

Soteria E-View is a medical device that received FDA 510(k) clearance on 2025-01-06. It is manufactured by Omega Medical Imaging, LLC. The 510(k) number is K242488.

When was Soteria E-View approved by the FDA?

Soteria E-View received FDA 510(k) clearance on 2025-01-06, under approval number K242488.

What company makes Soteria E-View?

Soteria E-View is manufactured by Omega Medical Imaging, LLC.

What is the FDA product code for Soteria E-View?

The FDA product code for Soteria E-View is JAA.

Other Devices by Omega Medical Imaging, LLC

K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly) K182834CS-series-FP with Optional ROI Accessory CA-100S K212890Nyquist.IQ K212336Soteria.AI

Related Devices (Code: JAA)

K161019Uroview FDPausch Medical GmbH K160301Platinum dRF Imaging SystemApelem-Dms Group K163210Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH K173395MECALL CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A K180651Uroview FD IIPausch Medical GmbH K180589DR 800 with MUSICA DynamicAgfa Healthcare N.V.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.